Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions

Not Applicable

Completed

• Conditions: Blood Pressure; Stress
• Interventions: Other: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF); Behavioral: Ambulatory Training

• Registration Number: NCT01921088
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The purpose of this study is to determine the potential efficacy of real-time functional magnetic resonance imaging neurofeedback (RT- functional magnetic resonance imaging (fMRI) -NF) in regulating brain activity and psychophysiological functions.

Detailed Description

The overall goal of the outlined study is to establish a real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) protocol aiming at modulating brain activity and psychophysiological functions. About two weeks after the initial training session it will be estimated how stable training effects have been. The two weeks in between, subjects will receive ambulatory training of the strategies via a smartphone-based application.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-08
• Study First Posted: 2013-08-13
• Status Verified: 2019-06
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

Inclusion Criteria

• Sufficient spoken and written knowledge of English
• Right-handedness
• Access to smartphone
• Availability to participate in the study

Exclusion Criteria

• Color blindness
• Presence of cardiovascular disease
• Medication intake affecting cardiovascular function
• Medical MRI contraindication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contingent	Ambulatory Training	Contingent RT-fMRI-NF of brain activity in the target region of interest
Non-contingent	Ambulatory Training	Sham RT-fMRI-NF of brain activity of previously recorded subject
Contingent	real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)	Contingent RT-fMRI-NF of brain activity in the target region of interest
Non-contingent	real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)	Sham RT-fMRI-NF of brain activity of previously recorded subject

Primary Outcome Measures

Name	Time	Method
Blood oxygenation level dependent signal of the target brain region of interest	study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)	blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity
Blood pressure	study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)	assessed via oscillometry, expressed in mmHg

Secondary Outcome Measures

Name	Time	Method
Feedback on adverse events during the scanner and ambulatory training	study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)	number of subjects reporting an adverse event

Trial Locations

Locations (1)

Korea University; 🇰🇷 Seoul, Korea, Republic of